Active Pharmaceutical Ingredients
In 2020, Anvisa published a new framework for Active Pharmaceutical ingredients (APIs). Since then, Anvisa has issued the Letter of Suitability of the Active Pharmaceutical Ingredient (CADIFA) for APIs used in the manufacture of new, innovator, generic and similar drug products, in accordance with RDC 359/2020.
Supporting Materials
Normative
- RDC 359/2020 - This Resolution institutes the Active Pharmaceutial Ingredient Dossier (DIFA) and the Letter of Suitability of the Active Pharmaceutical Ingredient (CADIFA)
- IN 289/2024 - Establishes the optimized analysis procedure where assessments conducted by Equivalent Foreign Regulatory Authority (AREE) are used for analysis the letter of suitability of the active pharmaceutical ingredient (CADIFA)
Guidance
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